Mandatory Healthcare Associated Infection Surveillance · Mandatory Healthcare Associated Infection...

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Mandatory Healthcare Associated Infection Surveillance Data quality statement July 2019

Transcript of Mandatory Healthcare Associated Infection Surveillance · Mandatory Healthcare Associated Infection...

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Mandatory Healthcare Associated Infection Surveillance Data quality statement July 2019

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About Public Health England

Public Health England exists to protect and improve the nation’s health and wellbeing

and reduce health inequalities. We do this through world-leading science, research,

knowledge and intelligence, advocacy, partnerships and the delivery of specialist public

health services. We are an executive agency of the Department of Health and Social

Care, and a distinct delivery organisation with operational autonomy. We provide

government, local government, the NHS, Parliament, industry and the public with

evidence-based professional, scientific and delivery expertise and support.

Public Health England

Wellington House

133-155 Waterloo Road

London SE1 8UG

Tel: 020 7654 8000

www.gov.uk/phe

Twitter: @PHE_uk

Facebook: www.facebook.com/PublicHealthEngland

Prepared by: Simon Thelwall, Olisaeloka Nsonwu, Sobia Wasti, Russell Hope

For queries relating to this document, please contact:

[email protected]

© Crown copyright 2019

You may re-use this information (excluding logos) free of charge in any format or

medium, under the terms of the Open Government Licence v3.0. To view this licence,

visit OGL. Where we have identified any third-party copyright information you will need

to obtain permission from the copyright holders concerned.

Published September 2019

PHE publications PHE supports the UN

gateway number: GW-736 Sustainable Development Goals

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Contents

About Public Health England 2

Introduction 4

Contact information 4 Accessibility 4 History 4 Purpose 7

Relevance, user need and perception 8

Users’ needs 8 User satisfaction 9

Timeliness and punctuality 11

Timeliness 11 Punctuality 12

Routine comparison/quality assurance of HCAI DCS data with voluntary

laboratory surveillance data 13

HCAI DCS and SGSS matching process 15

Results of HCAI DCS/SGSS matching 15 Resolution of unmatched cases from the voluntary surveillance scheme 18

Expected number of reports not captured by the mandatory surveillance scheme 18

Summary and conclusion 19

Accuracy and reliability 21

Coverage error 21 Measurement error 23

Non-response error 23 Processing error 23

Data collection and associated quality assurance 29

Quality assurance of the HCAI Data Capture System 29

Practice area 1: Operational context and administrative data collection 29 Practice area 2: Communication with data supply partners 31 Practice area 3: QA principles, standards and checks applied by data suppliers 32 Practice area 4: Producer’s QA investigations and documentation 32

Cost and burden 34

Cost 34 Burden 34

Confidentiality and disclosure control 36

Organisational level policies/procedures 36 Mandatory HCAI surveillance output level policies/processes 37 HCAI DCS system specific policies/controls 37

Appendix 40

Appendix 1: Current mandatory HCAI surveillance outputs 40

Appendix 2: Patient and laboratory information used for the matching process 41

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Introduction

This document describes many of the aspects of quality assurance (QA) surrounding

the routine publication of mandatory Healthcare Associated Infection (HCAI)

surveillance data.

Public Health England (PHE) will update this statement annually after the close of

every financial year.

Contact information

PHE welcome feedback on both the publication of mandatory HCAI surveillance data

and this associated ‘Quality Statement’.

Please contact:

The Mandatory Surveillance Team

HCAI and AMR Department

National Infections Service

Public Health England

61 Colindale Avenue

London, NW9 5EQ

Email: [email protected]

Accessibility

All mandatory HCAI surveillance outputs are published on GOV.UK.

All data tables are produced and published in a non-proprietary format (.ods). All

commentaries are published as PDFs with accompanying data tables being made

available as .ods files.

A comprehensive list of all current mandatory surveillance outputs and their location on

GOV.UK can be found in appendix 1.

History

Public Health England (PHE) has been managing the mandatory surveillance of

Staphylococcus aureus bacteraemia in England since April 2001. Mandatory

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surveillance was originally instigated in response to increasing levels of MRSA

bacteraemia across the English NHS and has subsequently been rolled out for other

HCAIs where there was a perceived issue/problem.

It has been mandatory for NHS acute trusts to report all cases of Meticillin-resistant

Staphylococcus aureus (MRSA) bacteraemia since April 2004. In October 2005

surveillance was enhanced to include patient-level data. Enhanced surveillance

involves collecting patient details such as NHS number, hospital number, date of birth,

and sex, as well as information concerning the patient's location, date of admission,

consultant specialty, and associated care details. All information is collected by acute

trusts via a real time web-based surveillance system (Healthcare Associated Infection

Data Capture System (HCAI DCS)). In January 2011 this scheme was extended to

include surveillance of Meticillin-sensitive Staphylococcus aureus (MSSA) bacteraemia.

Surveillance of Clostridioides difficile (previously Clostridium difficile) infection (CDI)

was originally introduced in 2004 for patients aged 65 years and over. This was then

extended to include all cases in patients aged 2 years and over in April 2007. Reports

are submitted using the same real time web-enabled system that is used to collect

enhanced MRSA and MSSA bacteraemia data. A similar enhanced dataset is

collected.

Escherichia coli (E. coli) bacteraemia surveillance was introduced in June 2011

following observed year-on-year increases via PHE voluntary surveillance and a

recommendation from the Advisory Committee on Antimicrobial Prescribing,

Resistance and Healthcare Associated Infection (APRHAI). Surveillance is again

undertaken via the HCAI DCS.

Between April 2013 and April 2018, all NHS organisations reporting positive cases of

MRSA bacteraemia are required to complete a Post Infection Review (PIR)1. This

process was introduced to support the delivery of zero tolerance on MRSA

bacteraemia, as set out by NHS England Planning Guidance2. A PIR was undertaken

on all reported MRSA bacteraemias with the purpose of identifying how a case

occurred and to identify actions which would prevent reoccurrences. It also enabled

identification of the organisation best placed to ensure necessary improvements are

made. From April 2018, only trusts with MRSA rates in the top 15% of trusts will have to

undertake PIRs for any MRSA cases. In addition, trusts which breach the threshold in

the course of a year will be expected to commence the PIR process for the remainder

of the year. From this point, PIR became a local process and was not reported to PHE3.

1 https://www.england.nhs.uk/patientsafety/wp-content/uploads/sites/32/2014/02/post-inf-guidance2.pdf 2 https://webarchive.nationalarchives.gov.uk/20161104031123/https://www.england.nhs.uk/everyonecounts/ 3 https://improvement.nhs.uk/documents/2512/MRSA_post_infection_review_2018_changes.pdf

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From April 2017 all NHS acute Trusts were required to undertake surveillance of

Klebsiella spp. and Pseudomonas aeruginosa bacteraemia. Alongside ongoing E. coli

bacteraemia surveillance these additional requirements are to support progress against

the Government’s ambition to reduce the number of Gram-negative bloodstream

infections by 50% by the end of financial year (FY) 2020/21.

Relevant Chief Medical Officer/Chief Nursing Officer letters detailing the introduction of

the various mandatory surveillance schemes can be found below:

Implementation of mandatory HCAI surveillance:

http://webarchive.nationalarchives.gov.uk/20130107105354/http://www.dh.gov.uk/en/P

ublicationsandstatistics/Lettersandcirculars/Professionalletters/Chiefmedicalofficerletter

s/DH_4003782

MRSA bacteraemia mandatory surveillance:

http://webarchive.nationalarchives.gov.uk/20130107105354/http://www.dh.gov.uk/en/P

ublicationsandstatistics/Lettersandcirculars/Professionalletters/Chiefmedicalofficerletter

s/DH_4112588

NHS Improvement guidance on PIR:

https://improvement.nhs.uk/resources/mrsa-guidance-post-infection-review/

CDI surveillance (patients aged 65 and over):

http://webarchive.nationalarchives.gov.uk/20130107105354/http://www.dh.gov.uk/en/P

ublicationsandstatistics/Lettersandcirculars/Professionalletters/Chiefmedicalofficerletter

s/DH_4125069

CDI surveillance (patients aged 2 and over):

http://webarchive.nationalarchives.gov.uk/20130107105354/http://www.dh.gov.uk/en/P

ublicationsandstatistics/Lettersandcirculars/Professionalletters/Chiefmedicalofficerletter

s/DH_073767

MSSA bacteraemia:

https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/215835/d

h_123292.pdf

E. coli bacteraemia:

https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/215619/d

h_126221.pdf

The ambition to halve healthcare associated Gram-negative bloodstream infections is

outlined in the NHS Improvement Provider Bulletin (15th March 2017).

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This includes a link to a letter from the NHS Improvement National Director for Infection

Prevention and Control providing and overview of the intention to the mandate the

reporting of Klebsiella spp. and Pseudomonas aeruginosa BSI:

https://improvement.nhs.uk/news-alerts/provider-bulletin-15-march/#infections

Purpose

Mandatory HCAI surveillance outputs are used to monitor progress on controlling key

health care associated infections and for providing epidemiological evidence to inform

action to reduce them. Data are unavailable from any other source and provide unique

information on infection levels.

Data are used to support the NHS objective of improving the quality and safety of

services and promoting patient choice by providing access to information on NHS

performance.

Data are used nationally for benchmarking purposes and for the performance

management of MRSA bacteraemia and CDI objectives set by NHS Improvement4.

Data/outputs are also routinely used to answer relevant Parliamentary Questions.

These data are also used to inform patient choice via the NHS Choices website5 and

the My NHS webpage6.

NHS acute trusts and CCGs use these data to monitor progress against these

objectives and to help inform action to reduce these infections locally. Mandatory

surveillance outputs are routinely used to appraise local/regional NHS management of

infection levels within their area.

The Klebsiella spp. and Pseudomonas aeruginosa bacteraemia surveillance outputs

will form an integral part of NHS Improvement’s strategy for the 50% reduction in Gram-

negative bacteraemia by the end of FY 2020/217.

4 https://improvement.nhs.uk/resources/clostridium-difficile-infection-objectives/ 5 http://www.nhs.uk/service-search/Hospital/se1/Results/3/-

0.0926785692572594/51.4953231811523/7/0?distance=25&metricGroupId=479&ResultsOnPageValue=10&isNational=0 6 https://www.nhs.uk/service-search/Performance/Highlights 7 https://improvement.nhs.uk/news-alerts/provider-bulletin-15-march/#infections

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Relevance, user need and perception

Users’ needs

Data/outputs are used for a variety of purposes by a range of organisations across the

health service. Details of the key stakeholders and associated data uses are outlined

below:

National users

Public Health England (National)

Data/outputs are used to:

• undertake epidemiological analyses at national/regional/local level

• provide relevant response to Parliamentary Questions (PQs) as/when required

Department of Health (DH)

Data/outputs are used to:

• routinely brief ministers on numbers/rates of HCAI (nationally and regionally) for all

infections reported via mandatory surveillance (MRSA, MSSA, E. coli, Klebsiella

spp. and Pseudomonas aeruginosa bacteraemia and CDI)

• inform/identify national level targets for interventions/reduction strategies

NHS England & NHS Improvement (National)

Data/outputs used to:

• identify/establish performance management/improvement methodologies

• set national/local/organisational level performance management targets/objectives

• assess performance against target/objective

My NHS

Data/outputs used to:

• Make comparisons for most recent 3 months to the same period in the preceding

year

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Local users

NHS England Local Offices

Data/outputs used to:

• assess NHS Trust/CCG Performance against targets/objectives at a local level

Local Public Health England (Field Epidemiology Service) / Public Health

England Centres

Data/outputs used to:

• assist in outbreak investigation as/when necessary

• inform public health initiatives/reports at a local level

NHS Acute Trusts

Data/outputs used to:

• inform Trust boards of the current organisational position in terms of key HCAIs

(MRSA, MSSA and E. coli bacteraemia and CDI)

• monitor progress against performance management objectives/targets

Clinical Commissioning Groups

Data/outputs used to:

• monitor progress against performance management objectives/targets

• assist in the commissioning of services from relevant acute level providers

User satisfaction

A routine ‘Stakeholder Engagement Forum’ is held every 3 months. This meeting

includes representation from a wide range of national level stakeholders as well as

from local NHS organisations such as CCGs and acute trusts.

Standing items on the meeting’s agenda include:

• recent publications

• experiences

• improvements

• future developments/updates

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Following the meeting a summary of the discussion/outcomes is produced and is

available on the GOV.UK website.

This summary covers:

• currently known uses of data/outputs

• user experiences (including changes/updates/improvements)

• stakeholder opinion of proposed/upcoming changes

Meeting feedback is used to improve/enhance ongoing engagement. It is also used to

inform future development and to ensure that data users remain central/integral to the

process.

Summary information from these meetings is routinely made publicly available.8

8 https://app.box.com/s/39ebi243ijuap4fsicf58479oot1ltdj

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Timeliness and punctuality

Timeliness

Mandatory HCAI surveillance data is published in as timely a manner as possible.

Data is signed off by acute trust Chief Executives 15 days after the end of each month

(for example sign off for each month is required by the 15th of the following month).

Data is published on a monthly, quarterly and annual basis according to a pre-

announced publication schedule published on GOV.UK. Dates are included for an

entire 12-month period.

The PHE official statistics publication calendar is available here:

www.gov.uk/government/statistics/announcements?utf8=%E2%9C%93&organisations

%5B%5D=public-health-england

The mandatory HCAI surveillance specific announcements for 2019 can be found here:

www.gov.uk/government/statistics/announcements?utf8=%E2%9C%93&keywords=mrs

a&topics%5B%5D=&organisations%5B%5D=public-health-

england&from_date=01%2F01%2F2019&to_date=&commit=Refresh+results

Monthly data tables

Monthly data is processed and analysed before being published on the first

Wednesday of the following month. This occurs between 2 and 6 weeks following the

end of a given month (depending on how the month falls). For example, January 2017

data was signed off on 15 February 2017 and then published on 1 March 2017. This is

2 weeks from sign off to publication.

Decreasing the amount of time between data sign off and monthly publication has been

investigated. It is; however, believed that adhering to these set sign off and publication

dates ensures transparency in terms of deadline/table production/publication without

reference to a changing schedule of dates. This far outweighs any minor benefits that

could be achieved by changing timings during months with longer lead times.

Quarterly epidemiological commentary (QEC)

The QEC is published approximately 2 months following sign off of the last full month of

data for inclusion. Publication occurs on the second Thursday of the final month of the

following quarter. For example, data up to and including December 2016 was signed off

on 15 January 2016 and was published on 9 March 2017.

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Decreasing the amount of time between sign off and publication has been considered.

However, doing so would not allow enough time to undertake relevant data quality

checks on either the data used for preparing the report or the report itself. Hence the

benefit of using the current publication schedule far outweighs any minor benefit that

might be achieved in reducing the lead time for the QEC publication.

Annual data tables and Annual Epidemiological Commentary (AEC)

Annual data tables and the accompanying AEC is published in early July each year. This is

approximately 3 months following the end of the financial year (FY) and the associated sign off

deadline of March data (15 April).

The annual data tables include counts and rates for both acute trusts and CCGs. Rate

calculation and associated quality assurance considerably increases the time required for table

production.

The AEC represents the most substantial HCAI mandatory surveillance output

produced/published each FY. The lead time necessary for analysis/compilation of data cannot

be underestimated. The document in its entirety includes in excess of 20 analyses from 2018

for all 6 infections subject to mandatory surveillance.

Punctuality

All published data outputs are published at 09:30 on the pre-announced publication date. To

date there has been one occasion where publication was delayed. On 10 July 2014 publication

of the annual data and accompanying Annual Epidemiological Commentary (AEC) was

delayed by approximately 30 minutes as a result of unforeseen delays in the process used by

Online Services for uploading statistics to the external website.

Further information on this delay is available on the UKSA website9:

There have been no publication delays in the last financial year (FY) 2018/19.

9 UKSA website

www.statisticsauthority.gov.uk/wp-content/uploads/2015/12/images-healthcareassociatedinfectionshcaistatistic_tcm97-

44590.pdf

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Routine comparison/quality assurance of

HCAI DCS data with voluntary laboratory

surveillance data

The Second Generation Surveillance System (SGSS) is a voluntary surveillance data capture

system used by laboratories to report cases of microbial infection from various samples, for

example blood, urine and faeces etc. Information on antibiotic and antifungal susceptibility is

also submitted where relevant. Although primarily an internal system used by healthcare

professionals, the data reported via this system is routinely compared to the mandatory data

collected via the HCAI DCS. This routine comparison between surveillance systems provides a

data quality check of the ascertainment of cases between SGSS and the HCAI DCS.

The following summary provides the results of this comparison for financial year 2017/18.

NB: Testing for C. difficile is a two-stage process, the second stage identifies C. difficile toxin.

Only C. difficile toxin-positive cases are reportable to the mandatory surveillance system. It is

not currently possible to differentiate reported C. difficile cases which have tested positive for

C. difficile toxins from those which have not, to an acceptable degree of accuracy on SGSS.

This is due to data quality and reporting issues in SGSS. Therefore, it is not currently possible

to include C. difficile data in the routine HCAI DCS/SGSS comparison as information on C.

difficile cases is not comparable.

Figure 1 compares the overall trends of E. coli, MRSA and MSSA bacteraemia reported to the

mandatory (HCAI DCS) and voluntary (SGSS) surveillance from financial year (FY) 2011/12 to

FY 2017/18. Figure 2 shows the same comparison between HCAI DCS and SGSS for

Klebsiella spp. and P. aeruginosa. This shows that, as expected, more cases of E.coli, P.

aeruginosa, MRSA and MSSA bacteraemia are captured via mandatory surveillance than via

voluntary surveillance; however, the overall trends of cases reported to both surveillance

schemes remain the same.

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Figure 1: Number of E. coli, MRSA and MSSA bacteraemia cases reported via the

mandatory surveillance and voluntary surveillance schemes, 2011/12* to 2017/18

Figure 2: Number of Klebsiella spp. and P. aeruginosa bacteraemia cases reported via

the mandatory surveillance and voluntary surveillance schemes, 2017/18

*Mandatory reporting of E. coli bacteraemia was initiated in June 2011 while mandatory reporting of Klebsiella spp. and P.

aeruginosa began in April 2017. Hence, only E. coli cases from 2012/13 onwards are included, and Klebsiella spp. and P.

aeruginosa cases in 2017/18 are included. S. aureus cases in which the susceptibility status is not known are excluded (1,951

cases in 2018/19)

-

5,000

10,000

15,000

20,000

25,000

30,000

35,000

40,000

45,000

2011/12 2012/13 2013/14 2014/15 2015/16 2016/17 2017/18

Re

po

rt

Financial year

E. coli (Mandatory) E. coli (Voluntary) MRSA (Mandatory)

MRSA (Voluntary) MSSA (Mandatory) MSSA (Voluntary)

-

2,000

4,000

6,000

8,000

10,000

12,000

2017/18

Re

po

rt

Financial year

Klebsiella spp. (Mandatory)

Klebsiella spp. (Voluntary)

P. aeruginosa (Mandatory)

P. aeruginosa (Voluntary)

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HCAI DCS and SGSS matching process

Not all cases reported to SGSS will be subject to reporting in the mandatory HCAI DCS.

Therefore, for datasets to be comparable, cases from SGSS have been limited based on

certain criteria. These include: -

• MRSA - all reported S. aureus bacteraemia from blood culture which are not

susceptible to meticillin, oxacillin, cefoxitin or flucloxacillin

• MSSA - all reported S. aureus bacteraemia from blood culture which are susceptible

to meticillin, oxacillin, cefoxitin or flucloxacillin

• E. coli bacteraemia - all reported cases of E. coli from blood cultures

• Klebsiella spp. Bacteraemia - all reported cases of Klebsiella spp. (including

Enterobacter aerogenes) from blood cultures

• P. aeruginosa bacteraemia - all reported cases of P. aeruginosa from blood cultures

Cases were then matched between surveillance systems on a case by case basis using a

number of ordered steps. SGSS cases within 14 days of the earliest cases from a patient were

excluded as duplicate episodes (see appendix 2 for details).

Results of HCAI DCS/SGSS matching

Total number and description of cases

There were more cases of bacteraemia reported to the mandatory surveillance scheme via the

HCAI DCS than were reported to the voluntary laboratory surveillance scheme (SGSS) for E.

coli, P.aeruginosa MRSA and MSSA. In 2017/18, 41,091 cases of E. coli bacteraemia, 4,299

cases of P. aeruginosa bacteraemia, 849 cases of MRSA bacteraemia and 11,948 cases of

MSSA bacteraemia were reported to the HCAI DCS, versus 39,435 cases of E. coli

bacteraemia, 4,252 cases of P. aeruginosa bacteraemia, 840 cases of MRSA bacteraemia and

10,479 cases of MSSA bacteraemia reported to communicable disease (CDR) and the

antimicrobial resistance (AMR) modules of SGSS (Table 1, Figure 3). Figures here differ from

that published in the most recent annual report on MRSA, MSSA and Gram-negative

bacteraemia and CDI due to case addition and deletion since its publication. There were more

cases of Klebsiella spp. bacteraemia reported to SGSS (9,909) than to HCAI DCS (9,745).

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Table 1: Total number of cases reported to the mandatory and voluntary surveillance schemes, 2017/18.

Organism causing bacteraemia

Voluntary Mandatory Ascertainment (%)

MRSA 840 849 99

MSSA 10,479 11,948 88

E. coli 39,435 41,091 96

Klebsiella spp. 9,909 9,745 102

P. aeruginosa 4,252 4,299 99

Total 64,915 67,932 96

Number of cases from the mandatory surveillance scheme (HCAI DCS) found in the

voluntary laboratory surveillance scheme (SGSS)

Reports were matched on a case by case basis in order to identify the proportion of individual

cases that are captured via the mandatory surveillance scheme (HCAI DCS) but are not

reported via the voluntary laboratory surveillance scheme (SGSS). This is opposed to the

comparison of overall/total cases undertaken above.

Table 2 shows the percentage of cases reported via the HCAI DCS that were also identified in

SGSS. Overall 63,130 (93%) cases reported to the HCAI DCS were also reported in SGSS.

The number of E. coli, Klebsiella spp., P. aeruginosa, MRSA and MSSA cases identified in

SGSS were 38,804 (94%), 9,158 (94%), 4,023 (94%), 740 (87%) and 10,405 (87%)

respectively. This suggests that approximately 7% of the total burden of infection episodes

across the organisms currently subject to mandatory surveillance are only reported via the

HCAI DCS and cannot be found in voluntary surveillance. This demonstrates the importance of

both the mandatory surveillance scheme and of the system used for data collection (HCAI

DCS). Further benefits are outlined in Strengths and weaknesses.

Table 2: Ascertainment of cases reported to the mandatory surveillance scheme which were identified in the voluntary surveillance scheme FY 2017/18

Organism causing bacteraemia

Matched (%)

Not-Matched

(%)

Total (%)

MRSA 740 (87) 109 (13) 849 (100)

MSSA 10,405 (87) 1,543 (13) 11,948 (100)

E. coli 38,804 (94) 2,287 (6) 41,091 (100)

Klebsiella spp. 9,158 (94) 587 (6) 9,745 (100)

P. aeruginosa 4,023 (94) 276 (6) 4,299 (100)

Total 63,130 (93) 4,802 (7) 67,932 (100)

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Number of cases from voluntary surveillance (SGSS) found in the mandatory

surveillance scheme (HCAI DCS)

Reports have been matched this way to demonstrate the effectiveness of the HCAI DCS in

capturing all cases of Gram-negative bacteraemia, Staphyloccocus aureus bacteraemia, which

are eligible for mandatory reporting. Figure 3 and Table 3 shows the number of cases reported

via voluntary surveillance (SGSS) that were also identified via mandatory surveillance (HCAI

DCS).

Overall 62,757 (97%) cases reported via SGSS were identified in the HCAI DCS. The number

of E. coli, Klebsiella spp., P. aeruginosa, MRSA and MSSA bacteraemia cases reported to the

voluntary surveillance scheme which were identified in the mandatory surveillance scheme

were 38,678 (98%), 9,069 (92%), 4,002 (94%), 804 (96%) and 10,204 (97%) cases

respectively.

Figure 3: Ascertainment of cases reported the voluntary surveillance scheme which were identified in the mandatory surveillance scheme

Table 3: Ascertainment of cases reported to the voluntary surveillance scheme which were identified in the mandatory surveillance scheme

Organism causing bacteraemia

Matched (%) Not-Matched

(%)

Total (%)

MRSA 804 (96) 36 (4) 840 (100)

MSSA 10,204 (97) 275 (3) 10,479 (100)

E. coli 38,678 (98) 757 (2) 39,435 (100)

Klebsiella spp. 9,069 (92) 840 (8) 9,909 (100)

P. aeruginosa 4,002 (94) 250 (6) 4,252 (100)

Total 62,757 (97) 2,158 (3) 64,915 (100)

0

10,000

20,000

30,000

40,000

50,000

MRSA MSSA E. coli Klebsiella spp. P. aeruginosa

Re

po

rts

Organism causing bacteraemia

Not-Matched

Matched

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Resolution of unmatched cases from the voluntary surveillance scheme

As part of the routine laboratory data check, laboratories with cases reported to the voluntary

surveillance scheme but not identified in the HCAI DCS (mandatory scheme) are contacted for

feedback on those cases. The cases are closed if:

• the unmatched case is subsequently identified in the HCAI DCS

• the unmatched case is added to the HCAI DCS as a new record

• there is a legitimate reason for it not being reported to the HCAI DCS (for example

post-mortem blood cultures).

The highest percentage of open unmatched cases from voluntary surveillance was observed in

Klebsiella spp. (95%; 820/840) and P. aeruginosa bacteraemia (94%; 235/250) . The highest

percentage of closed cases was observed in the unmatched reports of E. coli bacteraemia

(15%; 115/757) and MRSA bacteraemia (14%; 5/36).

Table 4: Follow-up for unmatched cases

Organism causing bacteraemia

Number of cases unmatched

Number of cases resolved (%)

MRSA 36 5 (14)

MSSA 275 25 (9)

E. coli 757 115 (15)

Klebsiella spp. 840 38 (5)

P. aeruginosa 250 15 (6)

Total 2,158 (3) 198 (9)

Expected number of reports not captured by the mandatory surveillance scheme

Assuming all currently open cases remain open, an expected number of cases eligible for

mandatory reporting which haven’t been captured by the HCAI DCS can be estimated. For

example, the results of this routine laboratory data check show that overall 93% (n = 63,130)

(Table 2) of cases reported to the HCAI DCS are captured on SGSS. It can be assumed that

the total number of open cases from SGSS (n = 1,960) represents 93% of an expected number

of unmatched cases which should be reported to the HCAI DCS; therefore, we could expect up

to 2,109 reports, across all organisms, which are not included in the mandatory surveillance

scheme. Using this, an ascertainment of cases reported to the mandatory surveillance system

compared to total number of cases eligible for mandatory reporting can be calculated as:

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(Total number of cases on the HCAI DCS

(Total number of cases on the HCAI DCS +

expected number of unmatched cases from SGSS)

) × 100

(67,932

67,932 + 2,109) × 100 = 97%

Using this method, the ascertainment of E.coli, Klebsiella spp., P. aeruginosa, MRSA and

MSSA bacteraemia cases reported to the mandatory surveillance system compared to the

estimated total number of cases of these bacteraemia eligible for mandatory reporting are

98%, 92%, 94%, 96%, and 98%, respectively. This demonstrates that the HCAI DCS has an

extremely high level of coverage.

Summary and conclusion

Identifying cases from the mandatory surveillance scheme (HCAI DCS) which were also

reported to the voluntary surveillance scheme (SGSS) demonstrates the percentage of Gram-

negative, MRSA and MSSA bacteraemia that are captured through mandatory reporting but

were not captured by SGSS (Table 2).

Overall 93% (n= 63,130) of all cases reported to the HCAI DCS can be accounted for in SGSS.

Of the 7% (n= 4,802) of cases not captured by SGSS, 48% (n= 2,287) are E. coli bacteraemia,

12% (n= 587) are Klebsiella spp. bacteraemia, 6% (n= 276) are P. aeruginosa bacteraemia,

2% (n= 109) are MRSA bacteraemia and 32% (n= 1,543) are MSSA bacteraemia.

This demonstrates the necessity of the mandatory surveillance scheme; relying on voluntary

surveillance alone would mean that an estimated 7% of the total burden of infection across the

organisms currently subject to mandatory surveillance would be missed.

Identifying cases from SGSS which were also reported to the HCAI DCS demonstrates the

effectiveness of the HCAI DCS as the surveillance system responsible for capturing Gram-

negative, MRSA and MSSA bacteraemia eligible for mandatory surveillance. (Table 3).

Overall 97% (n= 62,757) of all cases reported to SGSS are also accounted for in the HCAI

DCS.

The highest ascertainment of SGSS cases found in the HCAI DCS, was observed in E. coli

(98%, n= 38,678) and MSSA (97%, n= 10,204 ), the ascertainment for MRSA was 96%

(n= 804).

Taking into account the open cases identified in the voluntary surveillance scheme, the HCAI

DCS is capturing an estimated 98%, 92%, 94%, 96%, and 98%, of E.coli, Klebsiella spp., P.

aeruginosa, MRSA and MSSA bacteraemia cases, respectively, which are eligible for

mandatory reporting.

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In conclusion, the vast majority of data reported via PHE’s voluntary surveillance system

(SGSS) can be found in data reported to mandatory surveillance (HCAI DCS). This suggests

that the HCAI DCS can indeed be seen to provide an accurate national picture of the overall

burden of infection across the bacteraemia under mandatory surveillance in England.

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Accuracy and reliability

Under mandatory surveillance guidelines all laboratory confirmed cases should be reported.

Data should not be subject to sampling error, as the data collection is a census of all infections

rather than a sample (i.e. all laboratory-confirmed cases of these infections in England are

mandated to be reported to Public Health England). However, there is the potential for non-

sampling error.

Coverage error

Infection cases are reported by NHS acute trusts. As part of the verification process these data

are signed off on a monthly basis by the CEO of the acute trust by the 15th of the following

month (as outlined in Timeliness). This sign-off process provides formal assurance that the

data are accurate and complete. Published statistics; therefore, include details of all cases for

the reported time period.

On occasion; however, a notification is received that an amendment is required (undertaken

via the update process outlined in Practice area 2: Communication with data supply partners).

This may occur when sign off is required prior to full laboratory results being available. This

may result in additional cases being added following laboratory confirmation. Alternatively,

deletions may be required. A Trust may have entered case information for what they thought

was an MSSA bacteraemia but further laboratory information may confirm the case to actually

be an MRSA bacteraemia. In this situation, a CEO must request the deletion of the MSSA

bacteraemia episode and the addition of an MRSA episode (for the same time period). NHS

acute trusts or external agencies e.g. the Care Quality Commission may also perform audits of

local infection data. This can result in requests to add infection episodes that had not

previously been entered. Finally, an NHS Trust may ask to delete a case, if it is found to be a

duplicate of a case reported from another Trust (please see the Mandatory HCAI Surveillance

Protocol, section 9.2 for further detail on what constitutes a duplicate).

NHS acute trusts may request to alter their data in order to improve the CCG attribution of a

given infection record. The algorithm for CCG attribution is as described in the associated

Mandatory HCAI Surveillance Protocol (section 13.6, appendix 6). This process is undertaken

via an ‘unlock’ of the HCAI DCS. Further detail of the unlock process can be found in the ‘Data-

Specific Policy for Revisions/Amendments to MRSA bacteraemia, MSSA bacteraemia, E. coli

bacteraemia & Clostridium difficile Infection Mandatory Surveillance Data’.10 NB: This policy

will be updated to include Klebsiella spp. and Pseudomonas aeruginosa over coming months.

10

https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/509316/HCAI_Mandatory_S

urveillance_Data_Specific_Revisions_and_Corrections_Policy_March_2016.pdf

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A total of 102 (68%) acute trusts requested an unlock of at least one case across all organisms

affecting data in financial year 2017/18. This equated to 545 cases that were unlocked. 55% of

these unlocks were to add additional cases to a locked time period (n=301), 39% were

amendments (n=213) and 6% (n=31) were to delete records (Table 4).

Compared to the previous financial year (2016/17) there has been a 1% increase in the

number of trusts that requested unlocks to change their data; with an 84% increase in the total

number of unlocks. This dramatic increase in additions and amendments to data is due to the

inclusion of the new data collections, Klebsiella species and P. aeruginosa. Deletion of data

however have remained relatively stable. The number of unlock requests to add a case

increased from 176 to 301requests. The number of unlock requests to amend cases increased

from 81 to 213 requests. The number of deleted cases fell from 38 to 31 requests.

Table 4: Number of unlocked cases by data collection and unlock reason, for financial year 2017/18

Reason for unlock request

Data Collection Total

CDI MRSA MSSA E. coli Klebsiella

spp. P. aeruginosa

Add 45 6 20 101 80 49 301

Amend 56 3 9 55 85 5 213

Delete 9 2 6 10 4 0 31

Total 110 11 35 166 169 54 545

The HCAI DCS includes facilities to assist NHS acute trusts to identify duplicate infection

episodes within their organisation. A pop-up for potential duplicates at case entry is available in

order to determine that no duplicates have been entered for a designated time period.

Following sign off, as the CEO of an acute trust has verified their data as being accurate, data

used for statistical publications are not altered by the PHE mandatory surveillance team to

remove potential duplicate records. This may result in multiple listings of the same infection

episode in the dataset.

As the mandatory surveillance of healthcare associated infections dataset is a national-level

data collection, there is no over coverage; however, there is a possibility that some cases may

not be reported to the HCAI DCS, resulting in under coverage. In order to ascertain the level

and to rectify this, a consistency study is performed comparing voluntary reported laboratory

information for England with the mandatory surveillance scheme dataset. See Routine

comparison/quality assurance of HCAI DCS data with voluntary laboratory surveillance data for

more information.

Data changes between releases are highlighted in each publication, so that users are made

aware of any changes to historical data between publications. Further information on this

process is available on the caveats page of each routine publication.

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Measurement error

All mandatory HCAI surveillance data is collected via the HCAI DCS. The appendices of the

mandatory HCAI surveillance protocol detail definitions/guidance on each field in the data

collection. Therefore, there should be little concern over the interpretation of the questions by

different users, although it should be noted that some questions are subjective in nature,

asking the clinical opinion of the treating physicians.

Non-response error

Item non-response

The bulk of data used to produce the mandatory HCAI surveillance outputs are from

mandatory questions in the data capture system. This means that a response is required in

order to save the infection episode. Therefore, there will be only a marginal effect of non-

response error in the statistical outputs. The exceptions are the data collected on risk factors

for bacteraemias presented in the Annual Epidemiological Commentary (AEC), as the risk

factor/source of bacteraemia questions are not mandatory fields. However, there are

accompanying statements in the relevant sections of the AEC on the level of response for

these data, as well as, mention in the discussion of potential bias caused by missing data.

Unit non-response

While item non-response is extremely low, unit non-response (i.e. individual NHS acute trusts

who have not entered data and/or signed off data) is present. All outputs highlight such non-

responders. Non-responders are furthermore referred to NHS England for follow up/resolution.

Processing error

Data entry

Processing errors may occur during the data entry stage. The data collected via the HCAI DCS

is either entered by hand or partially uploaded (key questions required to save an infection

episode) using the healthcare associated infections data capture system upload wizard. Data

entry errors may occur, either because the source data at the acute trust is incorrect or

missing, or in the transcription process.

While it is not possible to provide a level or direction of bias through processing errors for the

entire data collection, it is possible to estimate the collective level of processing errors for 2 key

variables (date of birth and NHS number), which can be used as an indicator for the full data

collection. Section 13.6 (appendix 6) of the associated Mandatory HCAI Surveillance Protocol

details the process of CCG attribution. This is done through the use of both NHS number and

date of birth entered onto the healthcare associated infections data capture system. If either

the date of birth or NHS number is incorrect or missing, a match will not be made, and we will

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not receive necessary patient data from the NHS Spine. Assessing the percentage of all cases

which could not be attributed via a match with the NHS Spine provides an indication of data

entry errors. For FY 2017/18 Less than 2% of all cases are not attributed to a CCG through a

match with the Spine, where neither NHS number or date of birth are missing. Thus, we are

confident in the data entered onto the healthcare associated infections data capture system.

Data entry errors may occur, either because the source data at the acute trust is incorrect or

missing, or in the transcription process.

Data processing

As mentioned in Timeliness and punctuality, the accuracy of the data submitted to the

mandatory surveillance of healthcare associated infections scheme is assured by the CEO of

all of the reporting acute trusts via the monthly sign off process. Data is not amended after data

entry. Data is; however, processed in order to produce the statistics. All statistical processing is

performed independently by 2 scientists and then is cross-checked to verify that the data are

correct. In addition, when rates are calculated for our quarterly commentaries and annual data

tables and commentary, we also independently process the data used for denominators

(occupied overnight bed days (KH03 return) from NHS England and population data from the

Office of National Statistics).

Mandatory HCAI Surveillance Data in NHS performance management

NHS Improvement sets annual objectives for the continued improvement of CDI in England

and there has been a zero-tolerance policy for MRSA since April 2013. Organisations which

exceed their objectives are liable for financial penalties (up to and including 31 March 2014 for

CCGs and to date for acute trusts).

While PHE are not responsible for either the setting of these objectives, or the imposition of

financial sanctions, data collected, produced and published (as National Statistics) by PHE are

used by NHS England to set objectives for, and the performance management of, both CDI

and MRSA incidence rates.

As such, there is the potential for the introduction of bias into the statistics, as one of the

organisation types who are subject to targets (acute trusts) are responsible for reporting

infection numbers to PHE. Therefore, there could be a potential conflict between the use of

statistics for both epidemiology/public health and for performance management.

Speculation of potential ‘gaming’ in NHS acute trusts, through the empirical treatment of

suspected cases of CDI or MRSA bacteraemia without seeking microbiological confirmation of

the diagnosis (whereby cases are only reportable to the surveillance scheme if they are

laboratory confirmed) led PHE to investigate whether there was any evidence to corroborate

such concerns.

A separate data set, (the Quarterly Mandatory Laboratory Returns) which includes the

numbers of C. difficile toxin tests performed by laboratories in England between 2008 and

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2013, was queried to ascertain if there were any changes in the testing of C. difficile toxin over

a 6-year period in England. In brief, while there has been an overall decline in the count and

rate of C. difficile toxin testing in England over this time period, there has been a much greater

decline in the count and rate of CDI, with a much higher ratio of toxin tests performed per case

of CDI identified in 2013 than in 2008, leading to the conclusion that there is little evidence of

large-scale changes in testing practices over time and that ‘gaming’ by NHS acute trusts to

avoid exceeding CDI objectives and incurring financial penalties, has not been a major factor in

the reduction of CDI in England 11.

Furthermore, the number of deaths involving CDI or MRSA in England, where MRSA or CDI

were mentioned on death certification – a data source not related to the mandatory

surveillance scheme - have decreased in recent years12, providing further confidence in the

trends reported in HCAI Official Statistics as they are borne-out in other data sources.

Finally, data provided in Routine comparison/quality assurance of HCAI DCS data with

voluntary laboratory surveillance data, comparing the mandatory NHS acute trust reported data

with voluntary laboratory reported data indicates that the mandatory surveillance scheme, from

which Official Statistics are produced, is capturing cases in a similar order of magnitude to the

voluntary scheme and overarching trends overtime between the 2 datasets are conserved.

Together, these alternative data sources provide us with confidence in the reliability of the

data.

Strengths and weaknesses

The mandatory surveillance scheme has several strengths; the surveillance is at patient-level

and in real-time, including both risk factor data and information on both date of positive

specimen and date of inpatient admissions which allow for timing of detection to be

ascertained. These enhanced data provide a platform to identify potential interventional

targets, which could not be garnered from other surveillance schemes in place in England. In

addition, the surveillance scheme is a census of all microbiologically confirmed episodes of

bacteraemias and CDI, which provides up to 7%13 greater ascertainment than comparative

voluntary surveillance schemes (see Routine comparison/quality assurance of HCAI DCS data

with voluntary laboratory surveillance data). Such rich surveillance is unrivalled across much of

the world. The structured nature of the surveillance scheme provides for robust local and

11 Gerver et al., 2015. Clostridium difficile toxin testing by National Health Service (NHS) acute Trusts in England: 2008-2013.

Clinical Microbiology and Infection 21(9):850. Accessed via: www.sciencedirect.com/science/article/pii/S1198743X15004243 12 Deaths Involving Clostridium difficile, England and Wales: 2012

www.ons.gov.uk/peoplepopulationandcommunity/birthsdeathsandmarriages/deaths/bulletins/deathsinvolvingclostridiumdifficile

englandandwales/2013-08-22 13 Excluding CDI cases, due to issues with voluntary surveillance described in Routine comparison/quality assurance of HCAI

DCS data with voluntary laboratory surveillance data

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national data, with the potential for benchmarking of the data and comparison within

organisations and regions over time.

Well-completed patient identifiers allow for the utilisation of other data sources through direct

linkage, allowing for a fuller dataset without duplication of effort in the resource restricted NHS.

For example, data can be linked from the mandatory surveillance scheme with data from the

voluntary laboratory reports to access antimicrobial susceptibility information, or to Hospital

Episode Statistics for comorbidity information or prior healthcare interactions.

Live reporting from the HCAI DCS, for registered users, is available, covering the statistics and

other tabulations/graphical representations of these data as well. While regular pre-defined

statistical publications provide the timely reporting of data, with extensive stratification of the

data by organisation type and time periods on a website accessible to both healthcare

professionals and the general public.

However, even with the ability to link the mandatory surveillance data with other datasets, the

completion of the data return takes time and in the resource-restricted NHS, this leads to

variable field completion for the non-mandatory fields, which in turn restricts what the data can

be used for. In addition, there is the potential conflict between the use of these data for

epidemiological purposes by PHE and performance management/audit by others. While the

effect on data validity is not currently of great concern, as discussed in Mandatory HCAI

Surveillance Data in NHS performance management, the emphasis on performance

management surrounding reductions in MRSA bacteraemia and CDI could lead to an

emphasis on the infection prevention and control of these infections over others and, as we

know, that interventions developed to tackle MRSA bacteraemia and CDI have not had a

similarly reductive impact on other healthcare associated infections.

Comparison with devolved administrations

There are several differences between the English mandatory HCAI surveillance scheme and

the surveillance undertaken by the devolved administrations. These include case

definitions/protocols for diagnosing the infections, definitions re: inpatient episode vs. trust

apportioned/assigned episodes, age groups included in the surveillance schemes and the way

in which data are presented (i.e. time periods provided). Ignoring differences in the case

definitions used for the surveillance schemes, the population size of the devolved

administrations are quite different to England; therefore, crude counts of infections cannot be

compared between countries in the United Kingdom. Furthermore, as the population

demographics between the devolved administrations differ, as do the denominators used to

calculate any infection rates, these are also not directly comparable. Therefore, the data

provided in the published reports from Public Health Agency Northern Ireland, Public Health

Wales and Health Protection Scotland are not directly comparable with the data published by

Public Health England. Data on healthcare associated infections from the devolved

administrations can be found using:

• Wales - www.wales.nhs.uk/sites3/home.cfm?orgid=379

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• Northern Ireland -Error! Hyperlink reference not valid.

www.publichealth.hscni.net/directorate-public-health/health-protection/healthcare-

associated-infections-antimicrobial-resistanc

• Scotland - www.hps.scot.nhs.uk/data/healthcare-associated-infection-quarterly-

epidemiological-commentary/

Comparability over time

MRSA bacteraemia

Although data are comparable over time and can be displayed as a time series, there have

been 2 recent changes to the published MRSA bacteraemia outputs.

NHS England adopted a ‘zero tolerance’ approach to MRSA bacteraemias in April 2013. In

parallel all organisations reporting an MRSA bacteraemia were required to undertake a Post

Infection Review (PIR) (outlined in the PIR toolkit14 and History). The way in which MRSA

bacteraemia data was published was subsequently changed to incorporate the PIR outcome

(i.e. ‘assignment’). This has resulted in changes to how MRSA bacteraemia data is presented

in routine outputs. Attempts have; however, been made to retain published data trends through

the continued inclusion of historical data series (Trust apportioned cases) in parallel with the

new methodologies (Trust assigned cases) until the new time series is well established. This

approach has been taken in both the QEC and AEC.

In April 2014, the PIR process was amended, to include the additional assignment option of

‘Third Party’. This option encompasses cases where the case was deemed intractable or the

patient received care at another facility and it was at this other facility where there were

learning outcomes identified (see PIR toolkit and History History

for further detail). This has meant that there have been further breaks in the MRSA

bacteraemia time series. As such, we present Trust assigned data for financial year 2013/14

separately to Trust assigned data from financial year 2014/15 onwards, as the options for

assignment were not identical.

In April 2018 the PIR process was further amended15 and ceased to be part of the national

surveillance as performed by PHE. Instead, the PIR process is performed locally and only

among trusts with the highest rates of MRSA infection.

CDI

A change in the guidance on the laboratory testing algorithm for C. difficile detection in 2012

may have had an effect on the CDI time series. Based upon an NHS Centre for Evidence

14 Guidance on the reporting and monitoring arrangements and post infection review process for MRSA bloodstream infections

from April 2014 (version 2) www.england.nhs.uk/patientsafety/wp-content/uploads/sites/32/2014/02/post-inf-guidance2.pdf 15 Update on the reporting and monitoring arrangements and post-infection review process for MRSA bloodstream infections

https://improvement.nhs.uk/documents/2512/MRSA_post_infection_review_2018_changes.pdf

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Based Purchasing report in 2009.16 The DH commissioned a study to review the effectiveness

of many test kits available to detect C. difficile toxin in order to identify the combination of tests

which produced the most reliable results. Based on these results, a two-stage testing

algorithm17 has been recommended18. The DH has estimated, that if all acute trusts had

adopted the new testing algorithm compared to the single test algorithm between October

2010-September 2011, then a 17% reduction in the total number of CDI episodes would have

been expected19.Therefore, it is likely that a small proportion of the reduction in CDI seen in

England between 2010 and 2012 may be due to the gradual change in laboratory testing from

the former testing algorithm to the more accurate two-stage algorithm. However, it is worth

noting that any potential reduction caused by this change in testing, will have only occurred

once (i.e. at a single time point) for each reporting.

16 Clostridium difficile toxin detection assays CEP08054

https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/216192/dh_127743.pdf 17 Guidance on the reporting and monitoring arrangements and post infection review process for MRSA bloodstream infections

from April 2014 (version 2) www.england.nhs.uk/patientsafety/wp-content/uploads/sites/32/2014/02/post-inf-guidance2.pdf 18 Updates Guidance on the Diagnosis and Reporting of Clostridium Difficile.

www.gov.uk/government/uploads/system/uploads/attachment_data/file/215135/dh_133016.pdf

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Data collection and associated quality

assurance

The administrative data source used for collection of the data included in all of mandatory

HCAI surveillance outputs is the HCAI DCS. This is a real-time web-enabled system that

facilitates the collection of all mandatory HCAI surveillance data from NHS acute trusts. The

HCAI DCS is managed by the Healthcare Associated Infection & Antimicrobial Resistance

(HCAI & AMR) division at PHE. The HCAI & AMR division are also responsible for the

production of the mandatory surveillance outputs.

NHS acute trusts are required to report all episodes of MRSA bacteraemia, MSSA

bacteraemia, E. coli bacteraemia, Klebsiella spp. bacteraemia, P. aeruginosa bacteraemia and

CDI that test positive within their trust laboratories and fulfil associated case definitions to the

HCAI DCS. Further organism specific requirements for the submission of cases can be found

in the Mandatory HCAI Surveillance Protocol.

Quality assurance of the HCAI Data Capture System

The HCAI DCS has been assessed in line with the Risk/Profile matrix included in the

UKSA ‘Administrative Data Quality Assurance Toolkit’20 and has been judged as:

• high risk of data quality concerns due to complex data collection processes that are

hard to independently verify

• high public interest profile as the data represents an important public health issue

that has historically received substantial media coverage

Such an assessment/judgement demands assurances across a variety of practice

areas. The assurances currently in place are believed to ensure that the quality of

information held on the HCAI DCS is sufficient for the production of the Official Statistic

outputs relating to mandatory HCAI surveillance.

Practice area 1: Operational context and administrative data collection

Assurances in place across this practice area

As outlined above there is a protocol in place for the organisms covered by Mandatory HCAI

Surveillance. This protocol spells out in detail the exact processes/requirements for data

20 Administrative Data Quality Assurance Toolkit www.statisticsauthority.gov.uk/wp-content/uploads/2015/12/images-

qualityassurancetoolki_tcm97-44368.pdf

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suppliers (NHS acute trusts) in terms of data provision/transfer from NHS acute trusts to PHE

(HCAI DCS).

The mandatory HCAI surveillance protocol provides background on both the surveillance

processes and the mechanism employed for data collection (HCAI DCS). Details of exactly

what should be reported (surveillance inclusion criteria, core data set etc.) are also provided for

each organism under surveillance. Information on monthly reporting deadlines (as outlined in

Timeliness) is also provided.

The HCAI DCS is also supplemented by a complete and comprehensive set of user guides.

These guides provide system users with detailed information on all aspects of the system:

https://hcaidcs.phe.org.uk/WebPages/InternalContentPage.aspx

All infection episodes are entered onto the HCAI DCS by the NHS acute trust responsible for

testing the specimen. Acute Trust CEOs are required to sign off the infection data across all 6

infections collected via the HCAI DCS on the 15th of each month (see Monthly data tables for

further detail). CEO sign off constitutes formal agreement/assurance that a given month of data

is complete and correct. Acute trust CEO sign off is as mandated by the Chief Medical Officer

(CMO) June 200521: NHS acute trusts that have failed to sign off their data for 3 or more

months in a row are highlighted in all published data tables. The public reporting of

organisations that repeatedly fail to sign off serves the dual purpose of increasing awareness

of potential data quality issues and of highlighting those organisations that are failing to adhere

to their mandatory responsibilities. Further information on this process is provided in the

relevant data tables and their associated caveats.

Routine comparison/quality assurance of HCAI DCS data with voluntary laboratory

surveillance data details the routine comparisons that are undertaken between data

collected on the HCAI DCS and that collected via the voluntary surveillance system

(Second Generation Surveillance System). This routine audit not only enables us to

assess the completeness of the mandatory datasets but also enables us to

identify/investigate any differences that may exist in terms of the collection/recording of

data by region/geography, age, sex etc.

The Accuracy and reliability section provides a detailed investigation/assessment of the

accuracy/quality of surveillance data reported via the HCAI DCS. This section includes

assessment of potential sources of bias and error as well as discussion on the impact

that NHS performance management may have on reported data

21 Chief Medical Officer (CMO) June 2005: Mandatory Surveillance of Methicillin Resistant Staphylococcus aureas (MRSA)

Bacteraemias.

http://webarchive.nationalarchives.gov.uk/20130107105354/http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@

dh/@en/documents/digitalasset/dh_4112590.pdf

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Practice area 2: Communication with data supply partners

Assurances implemented across this practice area

There are established/maintained collaborative relationships in place between PHE and

NHS acute trusts (data suppliers). These are maintained via regional PHE colleagues.

PHE also routinely gauge the extent of interest from NHS colleagues in attending the

quarterly Mandatory HCAI Surveillance National Stakeholder Engagement Forum

(outlined in User satisfaction). If there is found to be significant interest in attending

such a forum an event specifically for NHS colleagues will be convened.

The HCAI DCS includes a facility for direct communication with system users. This

enables news items and other announcements/areas of interest to be communicated to

system users on an ad-hoc basis as/when required.

The PHE mandatory surveillance team routinely uses Granicus (formerly GovDelivery) to

deliver relevant communications to specific/targeted user/stakeholder groups. Use of this

methodology ensures the timely dissemination of information whenever required.

As outlined above there is a protocol in place for the organisms covered by Mandatory HCAI

Surveillance. This protocol spells out in detail the roles and responsibilities of NHS acute trusts

as data suppliers. It also includes detail on the process of data supply/transfer from reporting

NHS organisations to the PHE-managed HCAI DCS as well as associated sign off

requirements. The underlying requirements are as mandated by the CMO. More detailed

information on the various CMO mandates for undertaking mandatory HCAI surveillance can

be found in History

Organisationally PHE has a published ‘Official Statistics Corrections and Revisions

Policy’:

www.gov.uk/government/uploads/system/uploads/attachment_data/file/383416/PHE_R

evisions_and_Corrections_Policy_V01.00_Nov14.pdf

This is supplemented by a ‘Data Specific Revisions and Corrections Policy’ which

provides additional information relating specifically to mandatory HCAI surveillance:

www.gov.uk/government/uploads/system/uploads/attachment_data/file/509316/HCAI_

Mandatory_Surveillance_Data_Specific_Revisions_and_Corrections_Policy_March_20

16.pdf

This additional guidance accounts for the nuances of the real time surveillance

undertaken by the HCAI DCS. It also provides information/signposts for how data

suppliers can request/undertake an update to reported information.

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The HCAI DCS adheres to PHE requirements for security and confidentiality. These

arrangements are documented in detail in Confidentiality and disclosure control

NB: The PHE mandatory surveillance team is responsible for both the administration of

the HCAI DCS and for the publication of the various outputs. This means that there is

significant overlap between the QA steps/assurances undertaken taken in terms of both

the administrative source (HCAI DCS) and the published outputs.

Practice area 3: QA principles, standards and checks applied by data suppliers

Assurances in place across this practice area

The Mandatory HCAI Surveillance Protocol provides information on data collected via

the HCAI DCS. This is the definitive data entry guide for data providers (NHS acute

trusts) and helps to ensure that all organisations are adhering to a well-defined and

exhaustive set of definitions. Furthermore, certain fields/options are only triggered

when a certain response to a previous question is given. By linking questions in this

manner data quality is ensured – it is not possible for reporting organisations to

input/save inconsistent information. Further information on all data items collected and

the linkage/triggering of subsequent questions can be found in appendix 1 of the

Mandatory HCAI Surveillance Protocol.

Mandatory HCAI Surveillance Data in NHS performance management provides

discussion on the potential impact that the application of these data for performance

management purposes may have on reporting.

Routine comparison/quality assurance of HCAI DCS data with voluntary laboratory

surveillance data outlines the routine comparisons undertaken between HCAI DCS

data and data collected via the voluntary surveillance system (SGSS) for FY 2015/16.

This routine audit enables assessment of the completeness of the mandatory datasets.

Practice area 4: Producer’s QA investigations and documentation

Assurances in place across this practice area

Routine comparisons between HCAI DCS data and data collected via the voluntary

laboratory surveillance system (SGSS) are undertaken. This has previously been

outlined/discussed under practice area 3. Further detail can be found in Routine

comparison/quality assurance of HCAI DCS data with voluntary laboratory surveillance

data

Assessment on the impact of the use of these data for performance management purposes

may have on reporting has been undertaken (previously outlined under practice area 3).

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Further detail can be found in Mandatory HCAI Surveillance Data in NHS performance

management

Strengths and weaknesses provides an overview of the major strengths and weaknesses of

the data and of the associated administrative data source (HCAI DCS). This includes detail on

the issues inherent in the use of the data for published statistics/data outputs.

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Cost and burden

Cost

All mandatory HCAI Surveillance Outputs are produced from data collected via the

HCAI DCS. Data collected via this system are primarily for epidemiological purposes.

The Official Statistics outputs are by-products of this process and as such incur very

little in the way of additional cost.

In terms of the overall data collection process PHE are obliged to submit information on

the burden of assessment to the NHS Digital Challenging Burden Service (CBS). The

CBS assesses burden and provides associated recommendations to minimise burden.

Further information on CBS can be found on the NHS Digital website :

https://digital.nhs.uk/services/the-challenging-burden-service

Burden

The HCAI DCS was relaunched in October 2015. A number of changes/improvements

have been incorporated to reduce the burden placed upon data suppliers (NHS acute

trusts).

Recent improvements/developments include:

• the addition of a data upload wizard which enables data providers to batch upload

infection data (historically information had to be manually entered on a case-by-

case basis) - further details on the data upload process is available in the

associated user guide:

https://hcaidcs.phe.org.uk/ContentManagement/LinksAndAnnouncements/HCAIDC

S_Data_Upload_Wizard_UserGuide_v1.0.pdf

• the inclusion of easily accessible organisation specific summary information via the

dashboards functionality - this enables HCAI DCS system users to see their

summary position at a glance. (historically it was only possible to glean this

information via multiple different reports); further information on the various

dashboards is available in the associated user guides which are

• Summary Dashboard

https://hcaidcs.phe.org.uk/ContentManagement/LinksAndAnnouncements/HCA

IDCS_Dashboard_Summary_Dashboard_UserGuide_V3.0.pdf

• Benchmarking Dashboard

https://hcaidcs.phe.org.uk/ContentManagement/LinksAndAnnouncements/HCA

IDCS_Dashboard_Benchmarking_Dashboard_UserGuide_V2.0.pdf

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• Data Completeness Dashboard

https://hcaidcs.phe.org.uk/ContentManagement/LinksAndAnnouncements/HCA

IDCS_Dashboard_Data_Completeness_Dashboard_UserGuide_V2.0.pdf

• Data flows have been updated to enable more fluid/intuitive data entry - by ensuring

that relevant questions are only triggered as/when required by a previous response,

ambiguity in data entry is mitigated; this ensures that data entry is streamlined

wherever possible

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Confidentiality and disclosure control

Confidentiality and disclosure control underpins all statistical/data driven work undertaken by

PHE and is governed by organisational level guidance/policies. Local policies/procedures

supplement this guidance as/when necessary.

Organisational level policies/procedures

PHE has a range of organisational policies/procedures in place to ensure statistical

confidentiality and to avoid the unauthorised disclosure of data/individuals. These are:

• a Personal Information Charter which sets out the standards PHE staff are required

to comply with when handling personal information:

www.gov.uk/government/organisations/public-health-england/about/personal-

information-charter

• well defined organisation level ‘Caldicott Policy’ which sets out the framework

through which PHE implements the recommendations of the ‘Caldicott Report on

the Protection and Use of Patient Information’ (1997)22 - there is also an

‘Information Risk Management Policy”23 (both these documents are available to

staff via the PHE intranet)

• the ‘Anonymisation Standard’ devised by the NHS Digital and approved by the

Information Standards Board which provides a standard approach and a set of tools

to anonymise information to ensure that, as far as it is reasonably practicable,

information published does not identify individuals - this standard is a statutory

requirement for all public bodies publishing health and social care data24

• an internal Standard Operating Procedure for disclosure control which is consistent

with the GSS disclosure control policy25

• that all PHE staff, including temporary and contract staff, with access to personal or

confidential information are required to complete mandatory, information

governance training upon recruitment and then every year thereafter - this training

22 The Caldicott Committee Report on the Review of Patient-Identifiable Information

http://webarchive.nationalarchives.gov.uk/20130107105354/http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@

dh/@en/documents/digitalasset/dh_4068404.pdf

23 Information Risk Management Policy

http://phenet.phe.gov.uk/Policies-and-Procedures/Policy%20Documents/Information%20risk%20management%20policy.pdf

24 Anonymisation Standard for Publishing Health and Social Care Data Specification

http://content.digital.nhs.uk/media/18876/1523202010spec/pdf/1523202010spec.pdf

25 Disclosure control policy for tables

www.ons.gov.uk/ons/guide-method/best-practice/disclosure-control-policy-for-tables/index.html

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gives guidance to staff on how to protect and share information safely and

appropriately

PHE terms and conditions of employment include confidentiality clauses which apply to

those staff employed on PHE terms and conditions. Similar clauses are included in the

contracts of those staff employed on NHS contracts

Mandatory HCAI surveillance output level policies/processes

As well as the previously outlined organisational level policies/procedures, there are a number

of processes undertaken at the output level to ensure confidentiality and disclosure control.

These are that:

• all mandatory HCAI Surveillance data is collected and processed in accordance with

the Data Protection Act (1998)26._ patient-level data is not published

• disclosure control methods are adhered to at all times; published statistics are

tabular outputs, which are always at an aggregate level (for example tabulation by

acute trust or Clinical Commissioning Groups or larger geographies) meaning that

the risk of disclosure is extremely low

• all published outputs take into account the need to protect patient confidentiality

whilst at the same time ensuring that there is public access to official data and that it

meets requirements to assist the Secretary of State to undertake their function in

relation to the health service; in accordance with the Statistics and Registration

Service Act 2007 s4227

HCAI DCS system specific policies/controls

The HCAI DCS applies a strong password policy to user passwords as well as ensuring that

users of the system only have access to information relevant to their roles.

All PHE computers are connected to a local area network that is protected by firewalls

operating to accepted NHS standards, and are protected by PHE standard anti-virus software.

Unauthorised access to the HCAI DCS will be prevented as the access to the networked drive

and data on the PHE server, is controlled through a centralised directory at organisational

level. Access to the database is controlled through username and passwords issued to

identified and authorised users. Passwords are encrypted and follow the guidelines for using

and handling passwords as set out in the Centre for Protection of National Infrastructure

26 Data Protection Act 1998 www.legislation.gov.uk/ukpga/1998/29/contents 27 Statistics and Registration Service Act 2007 www.legislation.gov.uk/ukpga/2007/18/contents

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(CPNI) Password Guidance28. The user is required to configure 3 security questions as part of

the registration process.

Access to patient level data within the application, with or without Patient Identifiable

Information (PII), is restricted based on the organisational hierarchy.

National users have access to patient level data for all cases entered on the system

(full or pseudo-anonymised depending on organisation).

Sub-national users (CCGS, NHS Local Offices, PHE Centres etc.) have patient level

access for cases mapped to their organisation.

NHS acute trusts only have patient level access to the specific records that they

entered.

System administrators have access to PII for routine administrative work.

Access to these PII is granted on a need to know basis as identified by the System Owner and

would include NHS number, forename, initials, Soundex and date of birth.

Further information on roles and permissions can be found in the ‘Overview of Roles and Permissions’ user guide.

No PII is transmitted beyond PHE secure networks by PHE staff. Standard Operating

Procedures are in place regarding dissemination of data from the system to ensure

data are aggregate only with all PII removed prior to transmission beyond PHE.

Exceptions must be signed off by the Director of the Centre or Division to which the

data transfer applies and, where necessary, the Director will be responsible for

ensuring appropriate legal advice and guidance is sought.

External support colleagues will have access to anonymised data only, contained in a

separate support environment.

HCAI DCS backups are held in secure offline locations to which access is restricted.

Backups are never held on the live system and are encrypted. HCAI DCS data is

stored in a secure GIS approved location. All data is suitably encrypted using

appropriate algorithms. When the database is no longer required, the storage space is

released back to the ICT Storage Team for reuse within the storage system. All

physical IT infrastructure is disposed of in line with agreed PHE procedures. Backup

28 Centre for the Protection on National Infrastructure - Password Guidance

https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/458857/Password_guidanc

e_-_simplifying_your_approach.pdf

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tapes are disposed of by the Storage/Networking and Security teams in line with their

procedures.

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Appendix

Appendix 1: Current mandatory HCAI surveillance outputs

Monthly counts of cases

Monthly counts by NHS acute trust and Clinical Commissioning Group (CCG),

published as .ods documents on a monthly basis.

Monthly data tables include data for a rolling 13-month period and provide MRSA

bacteraemia, CDI, MSSA bacteraemia and E. coli bacteraemia, Klebsiella spp.

bacteraemia and P. aeruginosa bacteraemia counts by both acute trust and by Clinical

Commissioning Group.

Bacteraemia caused by MRSA, MSSA, E. coli, Klebsiella spp. or P. aeruginosa

Counts of cases by onset status, for trusts and CCGs, can be found at:

• MRSA - www.gov.uk/government/statistics/mrsa-bacteraemia-monthly-data-by-

attributed-clinical-commissioning-group

• MSSA - www.gov.uk/government/statistics/mssa-bacteraemia-monthly-data-by-

attributed-clinical-commissioning-group

• E. coli - www.gov.uk/government/statistics/escherichia-coli-e-coli-bacteraemia-

monthly-data-by-attributed-clinical-commissioning-group

• Klebsiella spp. - www.gov.uk/government/statistics/klebsiella-species-bacteraemia-

monthly-data-split-by-location-of-onset-by-ccg

• P. aeruginosa - www.gov.uk/government/statistics/p-aeruginosa-bacteraemia-

monthly-data-split-by-location-of-onset-by-ccg

C. difficile infection

Counts of cases by prior trust exposure, for acute trusts and CCGs, can be found at:

• www.gov.uk/government/statistics/clostridium-difficile-infection-monthly-data-by-

attributed-clinical-commissioning-group

Quarterly Epidemiological Commentary

Provides national aggregated counts and rates of cases by financial year quarter for

MRSA, MSSA, E. coli , Klebsiella spp. P. aeruginosa and CDI.

www.gov.uk/government/statistics/mrsa-mssa-and-e-coli-bacteraemia-and-c-difficile-

infection-quarterly-epidemiological-commentary

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Annual outputs

Annual counts and rates of cases are reported by acute trust and CCG. These are

accompanied by an epidemiological commentary detailing trends in rates, by age, sex

and region as well as infographics and short summaries per organism.

Appendix 2: Patient and laboratory information used for the matching process

Cases bacteraemia reported to the voluntary surveillance scheme (via SGSS) and the

mandatory surveillance scheme (via HCAI DCS) were identified based on:

1. NHS number, Date of Birth (DoB)

2. NHS number

3. Hospital number, DoB, Soundex

4. Hospital number

5. Specimen number, Laboratory Code, DoB, Soundex, sex, forename initial

6. Specimen number, Laboratory Code, sex, forename initial

7. Specimen number, DoB and forename initial or Soundex

8. Specimen number, DoB

9. Specimen number, Fuzzy DoB29, forename initial or Soundex

Subsequently, matching episodes30 were identified were an episode from the same

patient was identified in both SGSS and HCAI DCS.

29 The fuzzy matching of DOB is an NHS Digital accepted method of matching records to account for subtle differences in the

records that would originate from a data entry error. It assumes that the records belong to the same patient if only one

component (for example day, month or year) of the date of birth is different, while all other parts of the DOB and the NHS no.

are the same 30 Specimen dates ±14 days were used as an episode of bacteraemia is defined as 14 days